System and method for freeze-drying and packaging

Abstract

A system and method for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, a membrane configured to transmit air or solvent vapor out of the flexible container, and a membrane frame supporting the membrane and engaged with at least one column member. The at least one column member can be configured to maintain the membrane and the membrane frame a spaced distance from one or more contents received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration. A method can include inserting a biological material, for example, into a flexible container, freeze-drying the biological material, moving the freeze-dried biological material to a portion of the flexible container that includes at least one port, and sealing the biological material within the portion.

What is claimed is: 
     
       1. A system for freeze-drying and packaging a heat-sensitive substance, comprising:
 a container comprising a sealable material, the container having a first portion and a second portion wherein the first portion and the second portion are configured to pass the substance from within the first portion to within the second portion; 
 a membrane attachable to a surface of the first portion and configured to transmit air or solvent vapor out of, and resist liquid or contaminant passage into, the first portion; and 
 at least one port to allow for an introduction or a withdrawal of a liquid into or out of the container. 
 
     
     
       2. The system of  claim 1 , wherein the first portion and the second portion are defined as separate portions at an intermediate location of the container. 
     
     
       3. The system of  claim 2 , wherein the container is sealable at the intermediate location. 
     
     
       4. The system of  claim 2 , wherein the container is configured to be sealed at the intermediate location after the substance has passed into the second portion. 
     
     
       5. The system of  claim 4 , wherein the first portion and the second portion are configured to be detached after the container is sealed at the intermediate location. 
     
     
       6. The system of  claim 1 , further comprising a frame within the first portion, the frame coupled to the surface of the first portion. 
     
     
       7. The system of  claim 6 , further comprising at least one support member engaged with the frame and configured to support the frame. 
     
     
       8. The system of  claim 7 , wherein the at least one support member is integral with the frame. 
     
     
       9. The system of  claim 7 , wherein the at least one support member defines a U-shape, with the curvature of the U-shape engaged with the frame. 
     
     
       10. The system of  claim 6 , further comprising one or more magnetic or hook members coupled to or integrated with the first portion or the frame and configured to interact with an external magnetic member or an external support. 
     
     
       11. The system of  claim 1 , further comprising a removable cover protecting the membrane. 
     
     
       12. The system of  claim 1 , further comprising the heat-sensitive substance. 
     
     
       13. The system of  claim 12 , wherein the heat-sensitive substance comprises a biological material. 
     
     
       14. The system of  claim 12 , wherein the heat-sensitive substance comprises a non-biological material. 
     
     
       15. The system of  claim 1 , wherein the at least one port includes at least one port in each of the first portion and the second portion. 
     
     
       16. The system of  claim 15 , wherein the at least one port in the second portion is a reconstitution port that allows for the introduction of the liquid into the container. 
     
     
       17. The system of  claim 1 , wherein the membrane includes a membrane material selected from a porous polymer, a woven polymeric fabric, a non-woven polymeric fabric, glass fiber, or cellulose. 
     
     
       18. The system of  claim 1 , wherein the membrane comprises polytetrafluoroethylene. 
     
     
       19. The system of  claim 1 , wherein the sealable material comprises an inert medical grade plastic material. 
     
     
       20. The system of  claim 1 , wherein the sealable material comprises polyvinyl chloride, polypropylene, or high density polypropylene.